CASE STUDY Accelerating FDA Approval for Covid-19 Rapid Testing EUA Client Background In the face of a pandemic, one of the world'sleading medical device and healthcare companiesneeded emergency use authorization (EUA) todeliver rapid, cost-effective, and accessible testingto help mitigate the spread of the coronavirus(COVID-19). Challenges…
Category: Case Studies
CASE STUDY BioTech Company Client Background A multinational European company who developsand manufactures synthetic bone graft technology for orthopedic and dental applications. As a global leader in Orthobiologics, they are represented in over 30 countries andhave received numerous awards such as Biologics Company of the…
CASE STUDY Streamlining Clinical Data Entry with Automated EHR Integration Client Background This case study demonstrates the potential for technology to enhance efficiency and accuracy in clinical data management, ultimately improving patient care and research outcomes. Challenges Healthcare institutions frequently require clinicians to manually enter…
CASE STUDY Medical Device Manufacturer Enterprise application Standardization Client Background The client is a global, publicly traded medical device manufacturer focused on developing new capabilities in near-patient diagnosis, monitoring, and health management. They had achieved significant growth through acquisition and needed a way to standardize…
CASE STUDY Medical Device Manufacturer Regulatory Compliance Applications Client Background This European company develops, produces, and markets innovative devices for mechanically supporting the heart, and has developed a niche in pediatrics. Their products are known by cardiologists (where approved) to be highly reliable and engineered…